Effects of Propofol on Auditory Event-related Potentials and Brain Functional Connectivity in Patients With Supratentorial Glioma

Glioma Clinical Trial

Official title:

Effects of Propofol on Auditory Event-related Potentials and Brain Functional Connectivity in Patients With Supratentorial Glioma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05352685
• Other study ID #: wxx19950421
• Status: Recruiting
• Phase: N/A
• Start date: May 18, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: October 2023
• Source: Beijing Tiantan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The growth of gliomas often infiltrates important brain tissues and impairs subcortical fiber transmission, resulting in changes in global brain network connectivity. Most of the current anesthesia depth monitoring methods are based on healthy brain function population，which is difficult to reflect the sedation depth of glioma patients accurately. Therefore, this study aims to explore the characteristics of brain network connectivity in glioma patients under different sedation depths by electroencephalogram (EEG) and auditory event-related potential (AERP) methods, which may provide a research basis for sedative titration and anesthesia depth identification in glioma patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Age 18 - 60 years old;

2. American Society of Anesthesiologists (ASA) physical status rating I-II;

3. Supratentorial glioma (frontal, temporal, parietal, insular ;WHO grade I-III);

4. Native Chinese speaker;

5. Signed informed consent.

Exclusion Criteria:

1. Mallampati airway class=III;

2. BMI>30kg/m2;

3. Combined OSAS or Stop-BANG score=3;

4. Hearing impairment

5. Combined epilepsy symptoms

6. Recurrent or multiple intracranial tumors

7. Concomitant other psychiatric or neurological disorders

8. Pregnancy and lactation

Related Conditions & MeSH terms

• Glioma
• Propofol

Intervention

Drug:
• Propofol Injection
1% propofol is used for target-controlled infusion, and gradually increase the effect concentration at 0.2ug/ml. Make the subject's sedation depth reach light sedation and deep sedation respectively. EEG data were collected during wakefulness, light sedation, deep sedation, and recovery.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The amplitude of auditory event-related potential	The amplitude of MMN and P300	During the trial(up to 3 hours for each subject)
Primary	The latency of auditory event-related potential	The latency of MMN and P300	During the trial(up to 3 hours for each subject)
Secondary	Brain network functional connectivity	Using coherence ; phase slope index(PSI); phase locking value(PLV);phase lag index(PLI)to evaluate the brain network functional connectivity of subjects	During the trial(up to 3 hours for each subject)